SANOFI Pasteur EPSS 2017

• Research type

  Research Study

• Full title

  Enhanced passive safety surveillance of VAXIGRIP® (trivalent inactivated split virion influenza vaccine, Intramuscular route), INTANZA® 15μg (trivalent inactivated split virion influenza vaccine, Intradermal route) and VAXIGRIPTETRA® (quadrivalent inactivated split virion influenza vaccine, Intramuscular route) vaccines in Europe during the influenza season 2017/18 (FLU00065)

• IRAS ID

  229479

• Contact name

  Tim Caroe

• Contact email

  timcaroe@nhs.net

• Sponsor organisation

  Sanofi Pasteur Europe

• Duration of Study in the UK

  0 years, 2 months, 30 days

• Research summary

  This study is an observational study and is an Enhanced Passive Surveillance Study (EPSS). It will be conducted during Northern Hemisphere influenza season 2017/18 in routine clinical care setting where influenza vaccination with Inactivated Influenza (split virion) BP® vaccine is expected to be administered.

  People who have, or are just about to be, routinely vaccinated with Inactivated Influenza (split virion) BP® vaccine or their parents/legal guardians will be given a safety report card containing a phone number. Study participants will be asked to report adverse events occurring within seven days after vaccination.
  Investigators will be trained to raise vaccinees’ awareness to report any AR they may experience post-vaccination.

  Each vaccinee will be asked to report any suspected ARs by calling the dedicated local toll free phone number found on the SRC that connects the vaccinee to the Contact Support Centre. The emphasis will be to report suspected ARs occurring in the first 7 days following vaccination. However, all suspected ARs will be collected regardless of timing of occurrence. When a vaccinee calls the Contact Support Centre to report a suspected AR, a standardised interview will be conducted by trained personnel to collect the required safety information.

  The Contact Support Centre agent will collect contact details from the reporter in case follow up is needed, and provided the vaccinee or parent/legal guardian agrees to be re-contacted. Follow up will be performed for outcomes as per the SMP and will be conducted via telephone.

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  17/NW/0464

• Date of REC Opinion

  1 Sep 2017

• REC opinion

  Further Information Favourable Opinion